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Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
topotecan hydrochloride
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC

Sites / Locations

  • University of Alabama Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Phoenix (Hayden)
  • Comprehensive Blood and Cancer Center
  • Pacific Coast Hematology/Oncology Medical Group
  • Scripps Clinic
  • Veterans Affairs Medical Center - West Los Angeles
  • Southwest Cancer Care
  • University of California Davis Cancer Center
  • Kaiser Permanente-Southern California Permanente Medical Group
  • Sidney Kimmel Cancer Center
  • Oncology Clinic, P.C.
  • Shands Cancer Center
  • Baptist Regional Cancer Institute - Jacksonville
  • Oncology-Hematology Group of South Florida
  • Baptist Hospital- Pensacola
  • H. Lee Moffitt Cancer Center and Research Institute
  • Medical College of Georgia Hospital and Clinics
  • Evanston Northwestern Health Care
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  • Oncology and Hematology Associates, Inc.
  • Louisiana Oncology Associates
  • Alton Ochsner Medical Foundation Hospital
  • Henry Ford Hospital
  • St. Joseph Mercy Hospital
  • CCOP - Metro-Minnesota
  • St. John's Mercy Medical Center
  • Cooper Cancer Institute
  • St. Barnabas Medical Center
  • Cooper Hospital/University Medical Center
  • Santa Fe Hematology/Oncology
  • Rochester General Hospital
  • State University of New York - Upstate Medical University
  • Salem Research
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • Ireland Cancer Center
  • Penn State Geisinger Cancer Center
  • Central Pennsylvania Hematology & Medical Oncology Associates, PC
  • University of Pittsburgh Cancer Institute
  • Reading Hospital and Medical Center
  • Brown University Oncology Group
  • Cancer Centers of the Carolinas
  • Spartanburg Regional Healthcare System
  • Baptist Regional Cancer Center - Knoxville
  • Sarah Cannon-Minnie Pearl Cancer Center
  • Texas Cancer Care
  • University of Texas Medical Branch
  • University of Texas - MD Anderson Cancer Center
  • Joe Arrington Cancer Center
  • Scott and White Memorial Hospital
  • Office of Michael E. Lee
  • Hematology & Oncology Associates of Virginia
  • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • Waukesha Memorial Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 8, 2014
Sponsor
Case Comprehensive Cancer Center
Collaborators
Smith Kline Beecham
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1. Study Identification

Unique Protocol Identification Number
NCT00003917
Brief Title
Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
Official Title
An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
November 2001 (Actual)
Study Completion Date
November 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
Smith Kline Beecham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth. PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
Detailed Description
OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients. OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Levitan, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Veterans Affairs Medical Center - Phoenix (Hayden)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Pacific Coast Hematology/Oncology Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Veterans Affairs Medical Center - West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Southwest Cancer Care
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente-Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sidney Kimmel Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Oncology Clinic, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Baptist Regional Cancer Institute - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Oncology-Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Baptist Hospital- Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32522
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Medical College of Georgia Hospital and Clinics
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3620
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Oncology and Hematology Associates, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Louisiana Oncology Associates
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Alton Ochsner Medical Foundation Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Cooper Cancer Institute
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Cooper Hospital/University Medical Center
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Santa Fe Hematology/Oncology
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Salem Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Penn State Geisinger Cancer Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Central Pennsylvania Hematology & Medical Oncology Associates, PC
City
Lemoyne
State/Province
Pennsylvania
ZIP/Postal Code
17043-1440
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
Brown University Oncology Group
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Spartanburg Regional Healthcare System
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Baptist Regional Cancer Center - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Sarah Cannon-Minnie Pearl Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Cancer Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Joe Arrington Cancer Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Office of Michael E. Lee
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Hematology & Oncology Associates of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc.
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17513814
Citation
Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998. Erratum In: J Clin Oncol. 2007 Aug 1;25(22):3387.
Results Reference
result

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Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

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